A Randomised, Open, Placebo Controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax. [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PK of AZD1656 when administered with placebo or following repeated dosing of germfibrozil by assessment of AUC0-t, tmax, t1/2, CL/F and Vz/F [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]

PK of AZD1656 metabolite, when AZD1656 is administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC, AUC0-t, Cmax, tmax, t1/2 [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]

Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.

Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

Intake of another investigational drug within the last 30 days prior to enrolment.

Clinically significant illness or clinically relevant trauma.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01083212